MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37602

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

It was reported the patient had been having pain in their head and neck since they had acuscope myopulse therapy on their foot.The patient stated it could be the cold weather causing the pain.The pain started about 4-5 days prior to this report.A day prior to this report the patient¿s neck got stuck and was turned left.When the patient woke up today, they heard a ¿boing¿ sound in their head.The patient¿s neck was better the day of this report.The implantable neurostimulator (ins) was checked and the patient saw a question mark on the right ins.The left ins was on and okay when the patient checked it.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.Refer to manufacturer report #3004209178-2015-01354.

Manufacturer Narrative

Concomitant: product id 37602, serial# (b)(4), implanted: 2014-(b)(6), product type implantable neurostimulator.Product id 3387-40, lot# j0333616v, implanted: 2003-(b)(6), product type lead.Product id 748251, serial# (b)(4), implanted: 2003-(b)(6), product type extension.Product id 748251, serial# (b)(4), implanted: 2003-(b)(6), product type extension.Product id 3387-40, lot# j0331939v, implanted: 2003-(b)(6), product type lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4460689
• MDR Text Key: 18037438
• Report Number: 3004209178-2015-01355
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 01/28/2015
• Date Device Manufactured: 03/04/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00063 YR